Kornimate/medical-research-clean huggingface dataset:
compare-ii- vasomotion and imaging substudy

Conditions: Coronary Artery Disease

Summary: the purpose of the study is to compare strut coverage and neointimal thickness between everolimus eluting (xience-v® or promus® stent) and biolimus a9 eluting nobori stent 14 months after stent implantation and to determine the coronary endothelial function after everolimus eluting (xience-v® or promus® stent) and biolimus a9 eluting nobori stent 14 months after stent implantation by using supine bicycle exercise testing to assess coronary vasomotor response to exercise.

design: imaging and vasomotion substudy: 50 consecutive patients enrolled in the compare ii trial at the university of fribourg medical center will undergo follow-up re-angiography 14 months after index procedure with assessment of optical coherence tomography (oct) and vasomotion testing. endpoint substudy (all at 14 months): primary endpoint imaging: percentage of uncovered stent struts per lesion and mean neointimal thickness assessed by oct. vasomotion: coronary vasomotion assessed with quantitative coronary angiography at rest and during supine bicycle exercise.

Eligibility criteria:
inclusion criteria: * patient enrolled in the compare ii trial with successful stent implantation and absence of binary restenosis or severe progression of coronary artery disease at 14 months follow-up. * patient consent to undergo a non-scheduled follow- up angiography with imaging study and bicycle exercise testing exclusion criteria: 1. inability to provide informed consent 2. inability to perform a supine bicycle exercise stress test 3. binary in stent restenosis of the target vessel 4. acute coronary syndrome, acute myocardial infarction 5. patients with stent thrombosis following the index procedure 6. female of childbearing potential ( age ≤ 50 years and last menstruation within the last 12 months ), who did not undergo tubal ligation, ovariectomy or hysterectomy 7. known intolerance to heparin, contrast material 8. history of bleeding diathesis or known coagulopathy 9. age ≥ 80 years 10. hemodynamic instability 11. renal failure (creatinine clearance ≤ 40 ml/min) 12. oct / ivus technically not feasible

Keywords: drug-eluting stent coronary endothelial function coronary imaging
facilitating optimal routines in aging

Conditions: Mild Cognitive Impairment

Summary: loss of cognitive abilities leading to alzheimer's disease is progressive and destructive, leaving older adults disabled and unable to recall their past. the number of older adults with alzheimer's disease is expected to triple by the year 2050, yet little research examines amyloid beta deposition, executive function, and progression of disability. this study will test the influence of a novel and promising non-pharmacological intervention, strategy training, on the progression of disability in a sample of 150 older adults with mild cognitive impairment who have the option to complete a positron emission tomography (pet) imaging with pittsburgh compound b (pib).

this trial will test the effect of strategy training compared to enhanced usual care on change in disability among older adults with mild cognitive impairment (mci) and assess the extent to which central nervous system amyloid-beta deposition and neurocognitive function modify the relationship between strategy training and enhanced usual care on change in disability. assessments will be obtained at baseline, 8 week short assessment, 6 and 12 months post intervention. interventions, such as strategy training, focused on slowing emergence of disability despite underlying pathology may keep older adults as engaged in meaningful daily activities for as long as possible. this project tests a novel and promising non-pharmacological intervention and will inform our understanding of important effect modifiers- amyloid beta deposition and executive function- on change in performance of cognitively challenging daily activities. enhancing our understanding of amyloid beta deposition, executive function, disability, and a promising non-pharmacological intervention could support aging for millions of older adults who, in the near future, will experience disability related to mci.

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment * acknowledge difficulty with a daily activity * community dwelling exclusion criteria: * pregnant * central nervous system disorder (other than mci) * substance disorder in past 5 years * lifetime history of bipolar disorder, schizophrenia, or deemed unsafe to proceed in the study (e.g., untreated major depressive disorder) * severe medical condition that limits engagement in daily activities

Keywords: mild cognitive impairment cognition disability non-pharmacological intervention behavioral intervention amyloid deposition
pilot study on laser ablation of symptomatic benign thyroid masses

Conditions: Thyroid Nodule; Thyroid Cancer; Thyroid Neoplasms; Nodular Goiter

Summary: this proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.

thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. with the widespread use of ultrasound (us), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by us. laser ablation therapy offer potential for the thermal destruction of soft tissue structures. the ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses. in this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new fda-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. real time us monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. all ablated regions will be followed by us with doppler to document changes in size and vascularity. local effects on thyroid function for thyroid mass treatment will be measured on follow-up.

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan. * patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure. * the patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively. * all nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound. * required initial laboratory values: t3, t4. tsh, and thyroglobulin (for treated metastatic lymph nodes) * all patients must understand and sign a study-specific informed consent. exclusion criteria: * thyroid mass in contact with trachea or esophagus. * uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with ffp and platelets prior to procedure. (platelets must be ≥ 70,000/ul.) * aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.

Keywords: thyroid nodule thyroid cancer laser ablation litt nodular goiter thyroid mass
relieving burden of hypophosphatasia in adults with functional impairment due to chronic disease

Conditions: Hypophosphatasia

Summary: the study will evaluate safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 2 different doses (approved dose and lower dose) of asfotase alfa in adult participants with pediatric-onset hypophosphatasia (hpp).


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years at the time of signing the informed consent form * clinical diagnosis of pediatric-onset hpp based on signs and symptoms consistent with hpp * past medical history that includes at least one nonvertebral fracture (or pseudofracture) incurred without evidence of significant trauma. * the presence of a current fracture is not necessary, but for participants with current unhealed fracture(s) or pseudofracture(s) of the lower extremity(ies) (that is, femoral, tibial, fibular, metatarsal) documentation must be provided of the presence of these fractures for at least 3 months prior to screening (with or without surgical intervention) exclusion criteria: * medical condition, serious concurrent or recurrent illness and/or injury, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance or the assessment of study endpoints, including all protocol required evaluations and follow up activities, or may put the patient at risk * primary or secondary hyperparathyroidism or hypoparathyroidism * history of hypersensitivity to any ingredient contained in asfotase alfa * oral bisphosphonate use within 6 to 12 months (depending on the half-life of the drug as assessed by the investigator) and intravenous (iv) bisphosphonate use within 12 months prior to screening * denosumab use within 18 months prior to screening * asfotase alfa use within 6 months prior to screening * teriparatide/parathyroid hormone analog use within 2 months prior to screening * treatment with strontium or sclerostin inhibitors within 6 months prior to the first dose of study drug * vitamin b6 use for at least 2 weeks prior to screening * serum 25-hydroxy (25-oh) vitamin d below 20 nanogram (ng)/milliliter (ml), with repletion and recheck allowed at screening (results from local laboratory may be used if within 4 weeks of screening) * female patients who are pregnant, planning to become pregnant, or breastfeeding

Keywords: hypophosphatasia hpp pediatric-onset asfotase alfa
identification of epigenetic biomarkers for early detection of rheumatic disease

Conditions: Arthritis, Rheumatoid

Summary: • given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bdmards), selection of the optimal medication is imperative. current attempts to identify genetic factors that predict bdmard response and effectiveness in rheumatoid arthritis patients have been inconclusive. furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. this protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. subsequent research into such epigenetic changes may be indicative of bdmard response and/or safety. if such epigenetic signatures (egs) exist the business need for such tests will thus be supported.

two groups of patients will be assessed for the presence unique epigenetic signatures. the test group, having a bonafide diagnosis of rheumatoid arthritis (ra) and a control group of subjects who does not fulfill the american college of rheumatology's classification criteria for ra. a buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.

Eligibility criteria:
test patient inclusion criteria: * must fulfill the 2010 acr rheumatoid arthritis classification criteria. * must have at least moderate disease activity (cdai) for most recent disease activity score * any history of nsaid or corticosteroid use is acceptable * weight at time of blood draw must be greater than 110 lbs. * must be rf+ or ccp+ control patient inclusion criteria: * female (age: 18 - 80) * must not fulfill the 2010 acr rheumatoid arthritis classification criteria. * weight at time of blood draw must be greater than 110 lbs. * age will be within 5 years of a test patient. exclusion criteria: * male * age 17 or less * history of disease modifying anti-rheumatic drugs (dmards), or biologic dmards. * history of malignancy, except non-melanoma skin cancer * previous treatment for malignancy with chemotherapy agents * patient reported history of hiv, hepb, hepc, or tb

Keywords: epigenetic
association of multiple cardiovascular risk factors and erectile function across europe

Conditions: Cardiovascular High-Risk; Chronic Heart Failure

Summary: the purpose of the study is to evaluate the influence of cardiovascular risk factors, heart failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk patients.

association of cardiovascular risk factors and ed is likely due to an impairment of endothelial function resulting in a decreased activity of endothelial no-synthase, which plays a major role in physiology of erection. heart failure is also known to further contribute to endothelial dysfunction and hence, this could lead to erectile dysfunction. study objectives 1. evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients. 2. evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men. 3. long-term effects of cardiovascular drug therapy and cardiovascular diseases on erectile function. study design male patients across europe with cardiovascular diseases (chd, pad and heart failure) will be evaluated with a standardized questionnaire. grade of erectile dysfunction will be assessed using an ed-score, generated from two different questionnaires. 1. iief-5 - (international index of erectile function) 2. keed - (cologne evaluation of erectile dysfunction) primary endpoint the primary endpoint is the sum score of the ed rating scale of the keed (kölner erhebungsbogen zur erektilen dysfunktion, see appendix 1). erectile dysfunction is defined as reaching more than 17 points in the sum score. secondary endpoint the first secondary endpoint is the frequency of sexual activity and sexual desire. another secondary endpoint contains satisfaction with sex life and general well-being. men are defined as dissatisfied by answering "mixed" or "worse". follow-up: after 1 year, after 2 years.

Eligibility criteria:
inclusion criteria: * male patients with two or more cardiovascular risk factors or * male patients with a manifestation of atherosclerosis or * male patients with an ischemic or dilated cardiomyopathy * written informed consent exclusion criteria: * impairment of hormonal status * refusal of written informed consent * inability to complete the questionnaires

Keywords: heart failure cardiovascular high risk erectile dysfunction cardiovascular disease
hancock ii ultra porcine bioprosthesis hemodynamic study

Conditions: Aortic Heart Valve Diseases

Summary: since the first implant in september 1982, the medtronic hancock® ii has provided more than 20 years of excellent hemodynamic performance and durability. design improvements over the past generations include: low profile, flexible stent, supra-x™ supra-annular placement, t6 anti-calcification tissue treatment, modified fixation process, cinch® advanced implant system and ultra™ minimized sewing ring. valve sizing is a critical consideration in obtaining optimal hemodynamic performance. this is particular true in small aortic roots. a critical issue is the size of the prosthesis in relation to the patient's annulus. the objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the hancockò ultra™ bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.


Eligibility criteria:
inclusion criteria: * patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair. * patients who are able to provide informed consent. exclusion criteria: * concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair. * patients indicated for receiving a mechanical prosthesis. * patients who will have a replacement of existing valve prosthesis. * patients refusing or not able to provide informed consent. * patients requiring emergency surgery. * patients unable to participate in follow-up
parent training for youth with chronic symptoms

Conditions: Medically Unexplained Symptoms

Summary: the purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. the investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. the investigators also predict that this group will be acceptable and feasible for parents.


Eligibility criteria:
inclusion criteria: * presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms * symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation * participants must be proficient or fluent in english * children must live with their participating parent(s) at least 50% of the time exclusion criteria: * presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition * lifetime history of a psychotic disorder, bipolar disorder, autism, or intellectual disability (note: this criterion applies to child and parent(s)) * presence of severe emotional or behavioral problems that require a more immediate treatment
addition of spironolactone in patients with resistant arterial hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.

arterial hypertension resistant to therapy and requiring treatment with more then three antihypertensive drugs is common. at present there are is no standard therapy for resistant hypertension based on randomised clinical trials, neither data to guide addition of further drugs to therapy. recently some observational and retrospective trials reported good effect of spironolactone in patients with resistant hypertension, but these data were not validated by prospective randomised clinical trials. this is a multicentric, randomised, double blind clinical trial, which will evaluate the effect of addition of 25 mg spironolactone to current medication compared to placebo. the study will enroll patients with blood pressure over 140/90 mmhg during a clinical examination, which are using at least three antihypertensive drugs, one of them being a diuretic. average daytime systolic and diastolic blodd pressure will be evaluated by abpm (ambulatory blood pressure monitoring).

Eligibility criteria:
inclusion criteria: * patients over 18 years * resistant arterial hypertension: (blood pressure during clinical control exceeding 140/90 mmhg (or 130/80 mmhg in in diabetic patients or patients with renal disease with creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic exclusion criteria: * pregnant or breastfeeding women, women in fertile age without ruled out pregnancy * severe hypertension over 180/110 mmhg * renal insufficiency with creatinine over 180 umol/l or gfr lower than 40 ml/min * hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l * porphyria * hypersensitivity to the compounds of verospiron (richter gedeon, hungary) drug * patients taking any aldosterone antagonist (spironolactone, eplerenone, kanreone)

Keywords: resistant hypertension treatment spironolactone aldosterone antagonists resistant arterial hypertension refractory arterial hypertension
prevention of combat-related ptsd using attention bias modification (abm): a randomized controlled trial

Conditions: PTSD

Summary: military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. all these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for ptsd, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. the current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. if proved efficacious in reducing risk for posttraumatic symptoms abmt could be integrated into the army's resilience training program. thus, we propose a longitudinal double-blind randomized controlled study of abmt in soldiers. we will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 abmt sessions, 4 abmt sessions, 8 placebo training sessions, or no training. following 6 months of deployment to combat zone symptoms will be assessed again.


Eligibility criteria:
inclusion criteria: * combat soldiers exclusion criteria: * fluent hebrew

Keywords: attention bias modification resilience combat ptsd depression anxiety
electric acupuncture for icu-acquired weakness in mechanical ventilation patients

Conditions: Respiratory Failure; Sepsis; Multiple Organ Dysfunction Syndrome

Summary: intensive care unit acquired weakness (icu-aw) is common and dramatically affect recovery. the purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of icu-aw especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.

the principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. and electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sepsis or multiple organ dysfunction syndrome * within 48 hours from the initiation of mechanical ventilation exclusion criteria: * pregnant patients * neuromuscular disease or cerebrovascular accident * with temporary or permanent pacemaker * need to use neuromuscular blocking agents * inactivity for more than 5 days before icu admission

Keywords: weakness mechanical ventilation acupuncture therapy